SERVICES

임상시험

Clinical Development

바이오썬텍은 임상 연구 분야에서 고품질의 서비스를 제공할 것을 약속드립니다. 자체적인 표준작업지침서(SOP)와 다년간의 임상 실무 경험 및 전문 지식을 보유한 숙련된 인력을 통해 Phase I ~ IV & PMS (Post-Marketing Surveilance) 연구업무의 Regulatory Affairs, Clinical Operation, Project Management, Data Management 및 Statistical Analysis 서비스를 수행할 수 있습니다.

풍부한 경험과 바이오썬텍만의 노하우를 기반으로 의뢰사의 니즈에 맞춘 최적화된 임상시험 설계와 KGCP, ICH-GCP 에 부합하는 최상의 품질과 효율적인 서비스를 제공하기 위해 노력할 것입니다.

  • Product Development and Regulatory Strategy Consulting
  • Preparation and Document Validation of Registration Dossier
  • IND & NDA Application Support
  • Scientific and Medical Communication with Regulatory Authorities
  • Post-Approval Maintenance Support
  • Recruiting investigational sites
  • Supporting Regulatory Affairs group with regulatory authority submissions
  • Coordinating ethics committee approvals
  • Collecting and reviewing initial essential documents
  • Closing investigator contracts (clinical trial agreements)
  • Protocol Development
  • EDC System Development
  • Investigator and Site Assessment
  • Investigator’s meeting
  • Dossier Development & Translation
  • Site Initiation
  • Clinical Monitoring
  • Remote Monitoring
  • Close-out Visit
  • CSR(Clinical Study Report) Writing
  • Clinical Supplies and Logistics Management
  • Quality Audits
  • Project Management Plan
  • Monitoring Plan
  • Vendor Management
  • IP Management
  • SAE Management
  • Document Management